MAUDE Adverse Event Report: CORCYM S.R.L. PERCEVAL PLUS SUTURELESS AORTIC HEART VALVE; TISSUE HEART VALVE

Model Number	PVF-L
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	07/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a perceval plus heart valve, pvf-l was implanted in the patient.Reportedly, pvl was noted.As further reported, the surgical approach was a full sternotomy, and the patient annulus was sized as 25mm.A cabg was also performed as a concomitant procedure.The native valve was not bicuspid nor steno insufficient.The valve was explanted due to severe pvl and mild central leak.However, there was no mal-positioning or mis-sizing identified, nor any positioning difficulty noted.An inspiris 25mm was finally implanted instead.There was an additional cross-clamp time and by-pass time of 20 minutes.The patient remained stable throughout the delay in procedure, and the patient is doing well.
Additional Manufacturer Narrative
The manufacturing and material records for the device involved in this event, as they pertain to the reported issue, were retrieved and reviewed by the manufacturer¿s quality engineering.The results confirmed that this prosthesis satisfied all required material, visual, and performance standards at the time of manufacture and release.Steady flow test review was also performed.The images demonstrated the acceptable opened and closed leaflet performance of the perceval pvf-l sn# (b)(6).No anomalies are observed during the open/close cycle.The valve therefore meets the acceptance criteria of the steady flow test inspection defined in dedicated procedure at the time of release.Manufacturer is conducting an investigation on the returned device and will submit follow-up report upon completion of the investigation.
Additional Manufacturer Narrative
Updated sections b4, g3, g6, h2, h3, h6.The device was returned for investigation.The hydrodynamic testing conducted on the pvf-l was performed in order to assess the valve functionality.The effective orifice area (eoa) at 70 bpm, 5.0 l/min of cardiac output and mean backpressure of 100 mmhg is 3.24 cm2, above the iso 5840 minimum requirement 1.45 cm2.For a cardiac output of 5.0 l/min and mean aortic pressure of about 100 mmhg, the regurgitant fraction is 3.6 % and it is below the requirement of iso 5840 (rf% < 15%) for a prosthesis of equivalent size.No anomalies were observed during the whole cardiac cycle under normotensive and hypotensive conditions, with full coaptation of the leaflets.This is further confirmed by comparing the images from the test conducted before the product's release (steady flow test), which show no evidence of anomalous behavior.Additionally, a substantial correspondence can be observed in the morphology of the closing leaflets.To prepare the prosthesis for deployment and attempt to reproduce the reported event, the pvf-l valve was then collapsed using a demonstration accessory kit.During the simulated deployment within a silicon aortic root model (#25), no issues were encountered during the release and balloon inflation phases.Sealing at the annulus level was achieved and the valve remained securely positioned within the annulus.Subsequently, water was introduced into the aortic root from the outflow side.No paravalvular leakage was observed during the simulation.Given the static conditions of the test, the water level remained stable below the free edge of the leaflets.Based on the performed analysis, the reported event cannot be attributed to any intrinsic factors of the involved device, as no coaptation anomalies were observed during the functional test under hydrodynamic testing conditions as per iso 5840:2021.Furthermore, no paravalvular leaks were observed during the simulation of the static leak test, further confirming the stability of the positioning and sealing performance.Also, no material deficits were noted during the documents review.As such, the cause of the event cannot be traced to the device.

• Brand Name: PERCEVAL PLUS SUTURELESS AORTIC HEART VALVE
• Common Device Name: TISSUE HEART VALVE
• Manufacturer (Section D): CORCYM S.R.L.; via per crescentino sn; saluggia, vc
• Manufacturer (Section G): CORCYM CANADA CORP.; 5005 north fraser way; burnaby, bc
• Manufacturer Contact: laura mannino ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 22680750
• Report Number: 3004478276-2025-00161
• Device Sequence Number: 9473025
• Product Code: LWR
• UDI-Device Identifier: 08022057015389
• UDI-Public: (01)08022057015389(240)(17)280621
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P150011S013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: PVF-L
• Device Catalogue Number: PVF-L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2025
• Supplement Date Received by Manufacturer: 08/11/2025
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male